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A study to evaluate the safety and effectiveness of KPL-387 in patients with well-controlled recurrent pericarditis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Recurrent Pericarditis, a condition where the thin sac surrounding the heart becomes inflamed repeatedly. The research aims to evaluate the efficacy and safety of transitioning from standard treatments to a single medication called KPL-387. This medication is administered via subcutaneous injection, which is a method of delivering medicine through a small needle just under the skin.

Participants in the study will undergo a process to change from their current standard therapies to KPL-387 monotherapy, meaning the use of only one drug. The study includes a long-term extension period to observe how well the medication works over an extended duration. Throughout the course of the study, the focus is on monitoring how well the condition is managed and identifying any potential side effects during the transition and long-term use.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Transition to monotherapy

    The current standard therapies for recurrent pericarditis (an inflammation of the sac surrounding the heart) are changed to a single medication approach.

    The medication KPL-387 is administered as a subcutaneous injection, which means it is injected into the fatty tissue just under the skin.

    This phase aims to determine the effectiveness of different dosing regimens to prevent the return of pericarditis symptoms.

  2. Step 2

    Evaluation of efficacy

    The progress is monitored for 16 weeks to see if the pericarditis remains under control without a recurrence.

    A clinical endpoint committee, which is a group of independent experts, will review and confirm any instances of pericarditis recurrence.

  3. Step 3

    Long-term extension

    The use of KPL-387 continues into a long-term extension phase.

    This stage is designed to evaluate the long-term efficacy and safety of the medication.

    The annualized rate of pericarditis recurrence is monitored throughout the remainder of this phase.

Who can join the trial?

15 criteria

  • You must be able to understand the study information and sign a written informed consent, which is a formal document where you agree to take part in the study after being fully informed about it.
  • You must agree to follow all the rules and requirements of the study.
  • Women must either be postmenopausal (meaning you have not had a period for 12 months for medical reasons), have had surgery to prevent pregnancy (such as removal of the uterus or ovaries), or use a highly effective contraception method (a way to prevent pregnancy, such as an IUD or hormonal methods) with a failure rate of less than 1% per year.
  • Women who can become pregnant must not be pregnant or breastfeeding and must use effective birth control from the start of the study until at least 8 weeks after the last dose of the study drug.
  • Sexually active men must have had a vasectomy (a medical procedure to prevent pregnancy) or agree to use a condom or another highly effective birth control method with a partner.
  • Men must agree not to donate sperm, and women must agree not to donate eggs, until at least 8 weeks after the last dose of the study drug.
  • You must agree not to make major lifestyle changes, such as changing your exercise routine, that could affect your symptoms unless told otherwise by the study doctor.
  • You must be between 18 and 80 years old.
  • You must weigh at least 40 kg.
  • You must have a medical history of pericarditis (inflammation of the sac surrounding the heart) that meets specific diagnostic rules, such as having chest pain, a pericardial rub (an abnormal sound heard through a stethoscope), specific changes on an ECG (a test that records the heart's electrical activity), or a pericardial effusion (excess fluid buildup around the heart).
  • Your current recurrent pericarditis (repeated episodes of heart sac inflammation) must be well-controlled, meaning your CRP (a blood marker that shows inflammation in the body) is less than 0.5 mg/dL and your pain score is 3 or lower on a scale of 0 to 10.
  • You must have a history of CRP levels higher than 1 mg/dL during a previous episode of heart inflammation.
  • You must have been treated for your condition with standard medicine for at least 3 months and be on a stable dose.
  • You must be willing and able to stop your current pericarditis medications at a specific time after starting the study drug, as decided by the doctor.
  • Your routine adult vaccinations should be up to date or completed at least 2 weeks before the first dose of the study drug.

Who cannot join the trial?

20 criteria

  • You cannot participate if your pericarditis (inflammation of the sac surrounding the heart) is caused by tuberculosis (a serious bacterial infection), cancer, pus-forming infections, radiation, or physical injury to the chest area.
  • You are excluded if you have systemic autoimmune diseases, which are conditions where your immune system mistakenly attacks your own body.
  • You cannot join if you have significant myocardial inflammation (swelling of the heart muscle) or injury, shown by abnormal heart movement or high levels of cardiac troponin (a protein released into the blood when the heart muscle is damaged).
  • You are ineligible if you test positive for Hepatitis C or certain types of Hepatitis B (viruses that cause liver inflammation).
  • You cannot participate if your estimated glomerular filtration rate is too low, which is a measure used to check how well your kidneys are filtering waste from your blood.
  • You are excluded if you have had malignancy (cancer) in any part of your body within the last 5 years, excluding certain types of skin cancer that were successfully treated.
  • You cannot join if you have a current active infection or a history of frequent infections (more than 3 in the last year), such as infections in the urinary tract, chest, sinuses, or skin.
  • You are excluded if you have recently had a serious infection that required hospitalization or treatment with parenteral antibiotics (medicine given by injection or through an IV) or oral antibiotics within a specific timeframe.
  • You cannot participate if you have had an organ transplant, though a corneal (eye) transplant is allowed if it was done more than 3 months ago.
  • You are ineligible if your blood tests show low levels of hemoglobin (a protein in red blood cells that carries oxygen), white blood cells (cells that fight infection), neutrophils (a type of white blood cell), or platelets (cells that help blood clot).
  • You are excluded if your blood tests show high levels of bilirubin (a yellow substance produced by the liver) or high levels of AST or ALT (enzymes that indicate liver health).
  • You cannot participate if you have a known hypersensitivity (an allergic reaction) to the study drug or any of its excipients (the inactive ingredients used to make the medicine).
  • You are excluded if you have other medical conditions that the doctor believes might interfere with the study, such as significant diseases of the heart, kidneys, nerves, hormones, metabolism, lungs, digestion, or mental health.
  • You cannot join if you have had a pericarditis recurrence (a return of your symptoms) in the 3 months before the study starts.
  • You are ineligible if your pericarditis symptoms are worsening or if the doctor suspects your symptoms are about to return.
  • You are excluded if you previously used specific medicines called anakinra or rilonacept and they did not work for you, or if you had to stop them because of safety concerns.
  • You cannot participate if you have taken certain other treatments too close to the start of the study, during a required washout period (a time when a drug must leave your system).
  • You are excluded if you test positive for latent TB (a dormant form of tuberculosis) unless you have already completed the proper treatment for it.
  • You cannot join if you have a history of immunodeficiency (a weakened immune system) or if you test positive for HIV.
  • You are ineligible if a chest x-ray shows signs of cancer, tuberculosis, or other conditions that might interfere with the study.
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Investigated drugs

KPL-387 is an experimental medicine being tested as a single treatment to see how well it works and how safe it is for people with recurring inflammation of the lining around the heart. It is given to patients through a small injection under the skin.

What is already known about the treatment

KPL-387 - This medication is an experimental drug administered as a solution through a small injection under the skin. It is currently being studied in clinical trials to see if it can effectively treat people with recurring inflammation of the sac surrounding the heart. This drug works by targeting specific molecules in the body to calm down the immune system's overactive response that causes swelling. It is classified as an investigational biologic therapy designed to manage long-term inflammatory conditions.

Investigated diseases

Recurrent Pericarditis - This condition involves repeated episodes of inflammation in the sac that surrounds the heart. During an episode, the lining of the heart becomes irritated and swollen. The inflammation can cause symptoms to return even after an initial period of recovery. These cycles of inflammation can occur intermittently over time. Each recurrence represents a new instance of the sac becoming inflamed.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523234-66-00Protocol codeKPL-387-C212Estimated enrolment120 patientsSponsorKiniksa Pharmaceuticals GmbH

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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